Recall: D-1141-2023

Class II - Potentially Harmful

Class IIClassification

2023-08-11Initiated

TerminatedStatus

Baxter Healthcare CorporationFirm

Product

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Reason

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.